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TWN
Info Service on Intellectual Property Issues (Nov22/01) Geneva, 24 Nov (D. Ravi Kanth) — The credibility of the decisions arrived at the World Trade Organization’s 12th Ministerial Conference (MC12) in June appears to be very low, with members seemingly set to miss the deadline on extending the 17 June Ministerial Decision on the TRIPS Agreement to diagnostics and therapeutics due to “stonewalling” tactics adopted by major developed countries on behalf of Big Pharma, said people familiar with the development. At the WTO’s TRIPS Council meeting on 22 November, it has increasingly become apparent that a decision on paragraph eight of the Ministerial Decision on the TRIPS Agreement that states that “no later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics”, i.e. by 17 December – is unlikely to be met, said several participants, who asked not to be quoted. Major developed countries, which harbor Big Pharma such as the United States, the European Union, Switzerland, Japan, and the United Kingdom among others, showed no urgency in meeting the 17 December deadline at the informal TRIPS Council meeting. It has all along been an open secret since the conclusion of MC12 on 17 June that countries representing the interests of Big Pharma will not comply with paragraph eight to extend the limited Ministerial Decision to COVID-19 diagnostics and therapeutics, as it is more likely for developing countries to use the decision to produce and supply therapeutics and diagnostics, unlike vaccines, said a TRIPS negotiator, who asked not to be quoted. From the numerous questions raised by Switzerland, Mexico, the European Union, Japan, and the UK about the need to extend the TRIPS Agreement Decision to diagnostics and therapeutics, it seemed clear that developed country members would even “stonewall” any attempt to extend the 17 December deadline, the negotiator said. The Chair of the TRIPS Council, Ambassador Lansana Gberie of Sierra Leone, apparently informed that he held consultations with some members on 8-9 November about process-related issues. He sought to know whether members had any suggestions as to what can be done in the absence of consensus on extending the decision to diagnostics and therapeutics. Despite several meetings between the lead negotiators of the huge coalition of developing countries, which had first demanded the TRIPS waiver on 2 October 2020, for complying with paragraph 8 of the TRIPS decision on the one side, and those opposing any decision on extending the Ministerial Decision to diagnostics and therapeutics, on the other, the divide continued to persist on the issue, said another person, who asked not to be quoted. Apparently, several members suggested that the General Council should be convened before the 17 December deadline. Although the WTO calendar has yet to confirm the dates of the General Council meeting, according to sources, presently the General Council is expected to meet after the extension deadline on 19-20 December. The demanders such as South Africa, India, Sri Lanka, Nepal, Nigeria, and Indonesia among others have reiterated that paragraph 8 of the Ministerial Decision was a mandate to decide on its extension and not to open for discussion the text of the Decision. They were optimistic that a decision can still be agreed before the deadline. INDONESIA CALLS FOR URGENT DECISION Indonesia, which held the successful G20 leaders’ meeting in Bali last week, apparently said that there cannot be any delay in complying with paragraph eight while millions of people have died due to a lack of diagnostics and therapeutics. Indonesia said the ministerial decision on the TRIPS Agreement is “not only narrow in scope but also limited in time.” More importantly, Indonesia said while concerns are being raised as to why the developing countries have not used the agreed Ministerial Decision on vaccines, those raising these concerns are seemingly not ready to comply with paragraph eight. Indonesia said that the adoption of the Ministerial Decision has politically helped enhance cooperation with the framework of WHO, the Coalition of Epidemic Preparedness Innovations and the G20. As noted by the World Health Organization’s Director-General Tedros Adhanom Ghebreyesus, “the manufacturing capacity for medicines, diagnostics, vaccines, and other tools is concentrated in [a] few countries,” and as a result, many developing countries continue to have less access, Indonesia said. It argued that IP flexibilities are crucial for protecting public health, including access to medicines for all during emergencies. It is against this backdrop that diagnostics and therapeutics can play a major role in addressing the COVID-19 pandemic, which remains a major public health threat. Given the paucity of time, Indonesia said it is important to support the extension of the Ministerial Decision to therapeutics and diagnostics, emphasizing that “only through recovering together, that we could recover stronger.” CHINA CITES LACK OF PROGRESS At the TRIPS Council meeting, China said the discussion “on para 8 of the Declaration has yet to witness any substantial progress.” Expressing sharp concern over the continuing COVID-19 pandemic, with developing countries being the worst hit by the pandemic, including China, the Chinese TRIPS official said “the accessibility and affordability of diagnostic and therapeutic products remain a big challenge for many developing members, and China is no exception.” “Therefore, we fully understand the concerns and requests raised by proponents, and call for effective and prompt solutions in this regard,” China said, adding that “to fulfill our mandate within the remaining limited time, we have to accelerate the discussion in a more pragmatic and focused manner, and do not let perfect be the enemy of good.” China expressed hope that “the entrenched camps could meet each other half way, and through our collaborative hard work, we will be able to harvest the expected outcome by the deadline.” Some Members have apparently floated the idea of agreeing to a limited extension based on the configuration of a list of products covering both therapeutics and diagnostics. “NAYSAYERS” CONTINUE “STONEWALLING” TACTICS The “naysayers” to therapeutics and diagnostics such as Singapore, Switzerland, Japan, Korea, and the EU, continued with their earlier positions demanding concrete evidence that IPRs posed barriers before considering an extension to therapeutics and diagnostics, said people familiar with the discussions. The US did not make a statement at the informal meeting. However, according to various sources, the US has neither supported nor rejected the call for extension, and since 17 June has only indicated that it is undertaking domestic consultations. When asked to comment on the EU’s stand, an official said that Brussels is “ready to engage constructively with Members on this issue.” In a joint submission (IP/C/W/693), Switzerland and Mexico, based on selective information, argued that “we do not face a situation where we have an IP-induced lack of access to or a lack of manufacturing capacity of COVID-19 therapeutics and diagnostics. As a consequence, no adjustments to the IP system seem to be required”. However, Brook Baker, Professor of Law at Northeastern University and part of Health Gap, both based in the US, has in his analysis on the joint submission pointed out that the Mexico and Switzerland submission heavily relies on data supplied by Big Pharma, focusing on false evidence of suppressed demand rather than actual need. The joint submission, he adds, refers to the numerous voluntary licenses (VLs) signed but in actual fact these VLs exclude supply to a significant number of developing countries with large populations and that have suffered some of the most damaging rates of infection, adding that VLs often have additional troubling restrictions, for example, Pfizer’s license prevents R&D on combination regimens, co-formulation, and even co-packaging. The submission suggests that “tier-pricing” sufficiently addresses concerns about affordable access, but Prof. Baker reveals that “tiered prices are not necessarily affordable and are in almost all instances significantly more expensive than what competitive generic prices would be”. He gives the example of the price of molnupiravir to Thailand that was $300 a course of treatment and the price of nirmatrelvir+ritonavir to Brazil is reported to be near $250 a course of treatment. Even though these countries have GDP/capita that is a fraction of that in the US, they are asked to pay more than 40% of the US price. In his analysis, Prof. Baker states: “Instead of bragging that demand for tests and treatments is suppressed and thus that everything is okay, Switzerland and Mexico should be hanging their figurative heads in shame that HICs [high- income countries] have had broad and affordable access to out-patient antiviral medicines for nearly 10 months while LMICs [low- and middle-income countries] have barely received any supplies or global support for a robust test-and-treat rollout.” +
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